Table 3.
Important randomized clinical studies of pregabalin for the treatment of NeP conditions.
| Trial | Study design | PGB/comparator dosing and (patient number) | Primary outcome measure(s) | Results (95% CI) (p value) | 50% responders (%) | Dropouts due to AEs (%) |
|---|---|---|---|---|---|---|
| Indication: diabetic neuropathic pain | ||||||
| Rosenstock et al. [2004b] | Double blind, 8 weeks | PGB 300 (76) | Difference in mean pain score from placebo | −1.47 (−2.19 to −0.75) (0.0001) | 40 (0.001) | 10.5 |
| PBO (70) | 14.5 | 2.9 | ||||
| Lesser et al. [2004] | Double blind, 5 weeks | PGB 75 (77) | Difference in mean pain score from placebo | −0.15 (−0.76 to 0.46) (0.63) | 18 | 2.6 |
| PGB 300 (81) | −1.26 (−1.86 to −0.65) (0.0001) | 46 (S) | 3.7 | |||
| PGB 600 (82) | −1.45 (−2.06 to −0.85) (0.0001) | 48 (S) | 12.2 | |||
| Placebo (97) | 18 | 3.1 | ||||
| Richter et al. [2005] | Double blind, 6 weeks | PGB 150 (79) | Difference in mean pain score from placebo | −0.440 (−1.080 to 0.199) (0.18) | 19 | 2.5 |
| PGB 600 (82) | −1.264 (−1.890 to −0.639) (0.0002) | 39 (S) | 8.5 | |||
| Placebo (85) | 15 | 4.7 | ||||
| Tolle et al. [2008] | Double blind, 12 weeks | PGB 150 (99) | Difference in mean pain score from placebo | −0.27 (−0.87 to 0.34) (0.75) | 34.4 | 5.1 |
| PGB 300 (99) | −0.10 (−0.70 to 0.50) (0.75) | 33.3 | 11.1 | |||
| PGB 300/600 (101) | −0.91 (−1.51 to −0.31) (0.01) | 45.9 (S) | 12.9 | |||
| Placebo (96) | 30.1 | 3.1 | ||||
| Arezzo et al. [2008] | Double blind, 13 weeks | PGB 150–600 (82) | Difference in mean pain score from placebo | −1.28 (−1.96 to −0.60) (0.0003) | 49 (S) | 17.1 |
| Placebo (85) | 23 | 11.8 | ||||
| Bansal et al. [2009] | Double blind, crossover, 14 weeks | PGB 150–600 (48) | Difference in median pain score | 40 (30–60) | 48 | 12.5 |
| AMT 10–50 (47) | 42.5 (30–57) (0.87) | 34 | 36.2 | |||
| Satoh et al. [2011] | Double blind, 14 weeks | PGB 300 (136) | Difference in mean pain score from placebo | −0.63 (−1.09 to −0.17) (0.0075) | 29.1 (S) | 7.5 |
| PGB 600 (45) | −0.74 −1.39 to −0.09) (0.0254) | 35.6 (S) | 26.7 | |||
| Placebo (136) | 21.5 | 4.4 | ||||
| Indication: postherpetic neuralgia pain | ||||||
| Dworkin et al. [2003] | Double blind, 8 weeks | PGB 300/600 (89) | Difference in mean pain score from placebo | −1.69 (−2.33 to −1.05) (0.0001) | 50 (S) | 31.5 |
| Placebo (84) | 20 | 4.8 | ||||
| Sabatowski et al. [2004] | Double blind, 8 weeks | PGB 150 (81) | Difference in mean pain score from placebo | −1.20 (−1.81 to −0.58) (0.0002) | 26 (S) | 11.1 |
| PGB 300 (76) | −1.57 (−2.20 to −0.95) (0.0001) | 28 (S) | 15.8 | |||
| Placebo (81) | 10 | 9.9 | ||||
| van Seventer et al. [2006] | Double blind, 13 weeks | PGB 150 (87) | Difference in mean pain score from placebo | −0.88 −1.53 to −0.23) (0.0077) | 26.4 (S) | 8.0 |
| PGB 300 (98) | −1.07 (−1.70 to −0.45) (0.0016) | 26.5 (S) | 15.3 | |||
| PGB 300/600 (90) | −1.79 (−2.43 to −1.15) (0.0003) | 37.5 (S) | 21.1 | |||
| Placebo (93) | 7.5 | 5.4 | ||||
| Stacey et al. [2008a] | Double blind, 4 weeks | PGB 150–600 (91) | Median time to onset of pain relief | 3.5 days (<0.0001) | 46.7 (S) | 4.4 |
| PGB 300 (88) | 1.5 days (<0.0001) | 39.8 (S) | 18.2 | |||
| Placebo (90) | Not achieved | 18.4 | 4.4 | |||
| Achar et al. [2010] | Open comparative study, 8 weeks | AMT 25 (15) | % satisfactory | 13.4 | ||
| PGB 150 (15) | improvement of pain | 53.3 | ||||
| AMT 25 + PBG 150 (15) | (>75%) | 73.3 (<0.05) | ||||
| Barbarisi et al. [2010] | Open label, 4 weeks | (1) PGB 300 + TENS (8) | Difference in mean pain score between groups | (1–2): −13.88 (−15.22 to −12.55) | 0 | |
| (2) PGB 300 + TENS placebo (8) | (<0.0001) | 0 | ||||
| (3) PGB 600 + TENS (7) | (1–3): 1.53 (0.15–2.92) (0.02) | 0 | ||||
| (4) PGB 600 + TENS placebo (6) | (1–4): −7.55 (−8.99 to −6.11) (<0.0001) | 0 | ||||
| (2–3): 15.42 (14.0–16.84) (<0.0001) | ||||||
| (2–4): 6.33 (4.85–7.81) (<0.0001) | ||||||
| (3–4): −9.09 (−10.61 to −7.57) (<0.0001) | ||||||
| Baron et al. [2009a] | Open label, 4 weeks | 5% LIDO (50) | Percentage of response | 63.3 | 35.6 | 6 |
| PGB 150–600 (48) | (change from baseline ≥ 2 points or score ≤ 4 points in NRS) | 46.8 | 20.9 | 6.25 | ||
| Rehm et al. [2010] | Open label, 8 weeks | 5% LIDO (25) | Difference in pain level compared with combination phase at baseline | −11.8 | 4 | |
| 5% LIDO + PGB 150–600 (18) | −27.8 | 16.67 | ||||
| PGB 150–600 (14) | −5.4 | 7.14 | ||||
| PGB 150–600 + 5% LIDO (17) | −33.7 | 11.76 | ||||
| Indication: central neuropathic pain | ||||||
| Siddall et al. [2006] | Double blind, 12 weeks | PGB | Difference in mean pain score from placebo | 1.53 (0.92–2.15) (<0.001) | 22 (S) | 21 |
| 150–600 (70) | 8 | 13 | ||||
| Placebo (67) | ||||||
| Vranken et al. [2008] | Double blind, 4 weeks | PGB | Difference in mean pain score from placebo | 2.18 (0.57–3.80) (0.01) | 35 (S) | 15 |
| 150–600 (20) | 5 | 15 | ||||
| Placebo (20) | ||||||
| Kim et al. [2011] | Double blind, 13 weeks | PGB | Difference in mean pain score from placebo | −0.2 (−0.7 to 0.4) (0.578) | 8.2 | |
| 150–600 (110) | 3.7 | |||||
| Placebo (109) | ||||||
| Cardenas et al. [2013] | Double blind, 17 weeks | PGB 150–600 (110) | Duration-adjusted difference in mean pain score from placebo | −0.69 (−0.98 to −0.2) (0.003) | 19.1 | |
| Placebo (109) | 8.7 | |||||
| Indication: peripheral neuropathic pain due to other causes | ||||||
| Freynhagen et al. [2005] | Double blind, 12 weeks | PGB 150–600 (141) | Difference in mean pain score from placebo | −1.17 (1.90 to −0.45) (0.002)–1.38 (−2.11 to −0.65) (<0.001) | 48.2 (S) | 17.0 |
| DPN, PHN subjects | PGB 600 (132) | 52.3 (S) | 25.0 | |||
| PBO (65) | 24.2 | 7.7 | ||||
| Baron et al. [2009b] | Open label, 12 weeks | 5% LIDO (79) | Mean change in pain score during the combination phase | −0.7±1.2 | 1.3 | |
| 5% LIDO + PGB 150–600 (60) | −2.5±1.6 | 11.7 | ||||
| PGB 150–600 (63) | −0.6±1.3 | 1.6 | ||||
| PGB 150–600 + 5% LIDO (48) | −1.7±1.8 | 10.4 | ||||
| Zin et al. [2010] | Double blind, 4 weeks | PGB 75-600 + OXY 10 (24) | Percentage of response | 69 | 58 | 4.2 |
| PGB 75–600 + placebo (29) | 76 (0.581) | 66 | 3.4 | |||
| Pontari et al. [2010] | Double blind, 6 weeks | PGB 150–600 (218) | Percentage of response | 47.2 | ||
| Placebo (106) | 35.8 (0.07) | |||||
| van Seventer et al. [2010] | Double blind, 8 weeks | PGB 150–600 (127) | Difference in mean pain score from placebo | −0.62 −1.09 to −0.15) (0.01) | 39.7 (S) | 20 |
| Placebo (127) | 25.4 | 7 | ||||
| Jenkins et al. [2012] | Double blind, crossover, 2 weeks | PGB 300 (25) | Difference in mean pain score from placebo | −0.81 (−1.45 to −0.17) (0.02) | 4 | |
| Placebo (25) | 4 | |||||
| Simpson et al. [2010] | Double blind, 14 weeks | PGB 150–600 (151) | Difference in mean pain score from placebo | −0.25 (0.39) | 38.9 | 6 |
| Placebo (151) | 42.8 | 2.6 | ||||
| Moon et al. [2010] | Double blind, 10 weeks | PGB 150–600 (162) | Difference in mean pain score from placebo | −0.50 (−1.00 to 0.00) (0.049) | 26.1 (S) | 5 |
| Placebo (78) | 14.3 | 7.7 | ||||
| Gray et al. [2011] | Double blind, 4 weeks | PGB 150–600 (46) | Mean change in sharp and hot pain on the NPS | ‘Sharp pain’ p = 0.04; ‘hot pain’ p = 0.01 | 6.52 | |
| Placebo (44) | 6.82 | |||||
This table has been modified and updated from Table 4 in Toth [2012].
AMT, amitriptyline; LIDO, lidocaine; NPS, neuropathic pain scale; NRS, numerical rating scale; OXY, oxycodone; PGB, pregabalin; (S), indicates statistical significance was achieved with respect to this dose of medication in this particular study; TENS, transcutaneous electric nerve stimulation.